Setting up a commercial entity:
Plotting the Regulatory Affairs Road Map

Having firmly established a strong base of scientific support data, and having demonstrated in select experimental models that the product candidate was “safe and non-toxic”, the client was ready to proceed to the human “proof of concept” phase of development.

The company engaged us to guide them through the “first in man” clinical studies.

The discovery research that formed the basis of this commercial opportunity had been carried out in a medical school at a world-acclaimed university.


Accordingly, we reviewed their pre-clinical scientific data for completeness, and packaged it for submission to the local Internal Review Board (IRB). Their lead product candidates contained either a therapeutic drug, or a biological component, carried upon the same medical delivery device component. During the transition from the in vitro to the in vivo phase, we subcontracted a CRO to produce small quantities of clinical-grade cGMP test materials. Thus, we were ready to proceed with the definitive Proof of Concept studies.

For the initial safety study, we recruited 19 healthy volunteers to receive a single dose of either the drug or the biological product candidates, respectively. After proceeding efficiently with the due process, the IRB – directed study was performed and “no adverse events” were observed.

Based on these observations, we were ready to approach the FDA to proceed with an Investigational New Drug (IND) application. Since the client’s two lead product candidates both used the same medical device for delivery, but the active components were either drug or biological, we determined that it was necessary to request separate pre-IND meetings with both CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research).

We had paid close attention to stringent GLP compliance throughout the pre-clinical phase, which resulted in us having a package of support data that was very well received by the FDA and they complimented us on the quality and completeness of these deliverables.

In the successful CBER and CDER meetings, we presented the well-planned and detailed plans for the rational course of clinical development, where we mapped out a series of multi-center and multi-national clinical trials. Using familiar and well-credentialed lead Investigators, the clinical trials proceeded swiftly and effectively under our management.